Senior Director , Global Development Quality Assurance
Shanghai, China | full time | Job ID: 9663
As Senior Director Global Development Quality Assurance, you will support and lead the team in regulatory, compliance, and quality oversight, as well as establish and maintain collaborative internal & external partnerships globally and locally.
Your responsibilities are:
- Ensure compliance with global and local health authority regulations, align with BNT QMS and GDQA functions, and establish QA relationships with service providers and collaboration partners.
- Oversee inspection support (training, preparation, facilitation, follow-up, and CAPAs) while providing GCP compliance guidance, audit management, and leveraging global systems and tools.
- Deliver relevant quality metrics, trend observations, and performance indicators while driving risk-based approaches and innovative solutions to address complex challenges.
- Lead cross-functional efforts to embed quality in processes, operating models, and governance frameworks, while implementing change initiatives and driving quality-driven improvements.
- Prepare clear reports, contribute to compliance reporting, and maintain structured stakeholder interactions to ensure quality management frameworks are established and implemented.
- Provide strategic leadership for program and strategy development, collaborate with teams to adjust processes, and act as an ambassador for quality to enable organizational success.
What you have to offer:
- Advanced academic degree in Life Sciences
- Significant experience in Good Clinical Practice (GCP) related environment, and in interpreting GCP guidelines and Global/local regulations for the pharmaceutical industry typically gained through a minimum of 15 years
- Minimally ten years of inspection management experience
- Relevant experience in building and maintaining business partner relations that include partnering with and providing service to business functions, typically gained through a minimum of 10 years
- Strong and proven team leadership experience, gained through at least 8 years of experience
- Relevant operational experience in at least one of the following areas of expertise: Biostats, Data Management, Clinical Trial management, IRT, Pre-clinical, CMC, Clinical Pharmacology, Translational Sciences, Medical Affairs, Commercial, Regulatory Affairs, Companion Diagnostics, etc.
- Deep knowledge and experience in drug development, development of medical devices, clinical development, research operations, GCP, GLP, GPVP, GCP for Labs, general understanding of GMP
- Deep knowledge of process development expertise, industry standard problem-solving approaches, in alignment with Lean and Lean Six Sigma principles
- Strong knowledge and experience in Inspection Readiness, Inspection Preparation, and Inspection Management
- Experience in a quality management system
- Fluent in Mandarin and English both written and spoken
What we do with the BioNTainers:
We want to improve healthcare by making our innovations accessible worldwide. Therefore, we developed the first modular mRNA-manufacturing facilities based on a container solution called “BioNTainers”. Help us build a regional manufacturing network in Africa & Australia: With the region and for the region. As a part of the local team, driving the establishment of the regional end-to-end mRNA manufacturing solutions.
Benefits for you:
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Click here to find out more about what we do, the careers we offer ans also the benefits we provide. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:
Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
We are looking forward receiving your application.